Although stress urinary incontinence is a frequent problem in women, there are few treatment strategies short of surgery and little attention paid to the early years during which a woman experiences the problem. In The Surgeon: Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland, 2008 December; 6(6):366-72, Long et al state, “Urinary incontinence is a social burden for up to one-third of the adult female population.” In 1995, Sandvik, with the Norwegian Department of Public Health and Primary Health Care, reviewed 13 studies with the conclusion that there was an incontinence prevalence of 20-30% in young women and 30-40% in middle aged women, with almost half having predominantly stress incontinence and one third having mixed incontinence. A study by Nygaard, Thompson, Svengalis, and Albright (1994) showed that 28% of 156 nulliparous college varsity athletes with a mean age of 19.9 years experienced urine loss during sports. Seventeen percent of the female athletes reported that their problem began in junior high, and 40% reported that the problem began in high school. A retrospective study of 104 female Olympians (16.7% nulliparous) (Nygaard, 1997) reported 35.8% of the athletes experienced UI during sports.
Vaginal pessaries have been used for decades, but they have been generally more successful in the treatment of pelvic organ prolapse than urinary incontinence. These pessaries do not account for the angulation between the upper and lower vagina that occurs when a woman is in an upright position, and drawings depicting their proper placement in vagina virtually all depict them placed into a straight vagina. Effectiveness of pessaries depends upon their ability to provide appropriate support when the woman is in an upright position as this is the position in which incontinence generally occurs. Because of their shape and rigidity, when placed in the vagina existing pessaries force the vagina into a straight configuration and either support the bladder more than the urethra, or they support both the urethra and the bladder eliminating the posterior urethrovesical angle (FIG. 10).
U.S. Pat. No. 4,823,814 by Drogendijk et al. discloses a pessary for treatment of both prolapse of internal female sex organs and urinary incontinence. The pessary is oval-shaped and bowed along a major axis of the oval. An elastic strip along an edge of the pessary may be expanded to close off the urethra and inhibit urine flow.
Pelvic floor strengthening exercises are an occasional topic of discussion between doctor and patient, but are rarely employed in a systematic way. Until the problem becomes particularly bothersome, women typically deal with the problem by using absorbent pads and curtailing activities that are likely to cause incontinence. Vaginal pessaries have been more helpful for pelvic organ prolapse than for incontinence, are used primarily in the elderly, and have the disadvantage of only being available when prescribed by a qualified health practitioner. Many active women would prefer to handle the problem themselves, much as they do with tampons for the inconvenience of menses, until the problem is severe enough to consider surgery. To have a disposable product that they could use as desired would be attractive and would allow many women to continue physical activities that they currently avoid.
U.S. Pat. No. 6,808,485 discloses a helical device formed of a compressible, resilient, biocompatible material to relive urinary incontinence. The device is insertable and removable by the user. U.S. Pat. Nos. 4,823,814 and 6,808,485 are incorporated herein by reference in their entireties.